A Randomized, Phase 2, Neoadjuvant Study of Weekly Paclitaxel With or Without LCL161 in Patients With Triple Negative Breast Cancer
Trial ID or NCT#
To assess whether adding LCL161 to weekly paclitaxel enhances the efficacy of paclitaxel in women with triple negative breast cancer whose tumors are positive for a defined pattern of gene expression
A Phase II Multi-center, Open-label, Neoadjuvant, Randomized Study of Weekly Paclitaxel With or Without LCL161 in Patients With Triple Negative Breast Cancer
- - Histologically confirmed diagnosis of invasive triple negative breast cancer - Known status for the LCL161 predictive gene expression signature as determined during molecular pre-screening - Candidates for mastectomy or breast-conserving surgery - Primary tumor of greater than 20 mm and less than or equal to 50 mm diameter measured by imaging (previous Amendment #3 was tumor size greater than 10 mm) - Regional nodes N0-N2 - Absence of distant metastatic disease - ECOG performance status 0-1 - Adequate bone marrow function - Adequate liver function and serum transaminases - Adequate renal function
- - Bilateral or inflammatory breast cancer (bilateral mammography is required during Screening/baseline); locally recurrent breast cancer - Patients currently receiving systemic therapy for any other malignancy, or having received systemic therapy for a malignancy in the preceding 3 months - Uncontrolled cardiac disease - Patients who are currently receiving chronic treatment (>3 months) with corticosteroids at a dose ≥ 10 mg of prednisone (or its glucocorticoid equivalent) per day (inhaled and topical steroids are allowed), or any other chronic immunosuppressive treatment that cannot be discontinued prior to starting study drug - Impaired GI function that may affect the absorption of LCL161 - Pregnant or breast feeding (lactating) women - Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 180 days after study treatment - Other protocol-defined inclusion/exclusion criteria may apply
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